An Exploratory, Double Blind, Randomized, Placebo-controlled, 2-way Cross-over Study to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With COPD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14
研究概览
简要总结
This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects,
- •40 to 80 years of age,
- •with a documented diagnosis of mild, moderate or severe chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >20-pack year history of smoking, a post-bronchodilator 40% ≤ FEV1 ≤ 80% of predicted normal and post-bronchodilator FEV1/FVC < 70% who have signed an informed consent form (ICF) prior to the initiation of any study-related procedure (Post bronchodilator refers to 30 minutes after the inhalation of 400 µg of salbutamol)
- •Subjects who demonstrate a plethysmographic functional residual capacity >120% predicted normal
排除标准
- •No COPD exacerbations within 6 weeks prior to dosing,
- •no concomitant lung disease such as asthma,
- •no requirement for long term oxygen treatment or history of lung reduction surgery.
- •No medical conditions that would interfere with the performance of spirometry or clinical exercise testing.
- •Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from participating in the study e.g. uncontrolled hypertension or unstable ischemic heart disease
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Sequence 1: Indacaterol 300μg followed by Placebo
In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
干预措施: Indacaterol 300μg (Drug)
Sequence 1: Indacaterol 300μg followed by Placebo
In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
干预措施: Placebo (Drug)
Sequence 2 : Placebo followed by Indacaterol 300μg
In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
干预措施: Indacaterol 300μg (Drug)
Sequence 2 : Placebo followed by Indacaterol 300μg
In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
干预措施: Placebo (Drug)
结局指标
主要结局
Inspiratory Capacity (IC) at Peak Time and at Isotime on Day 14
时间窗: Day 14
Inspiratory capacity (IC) at peak time and at isotime were the primary pharmacodynamic (PD) variables of interest. IC was measured at two minute intervals during exercise. Isotime was defined as the time the subject was still exercising in the shortest of all sub-maximal exercise tests (3-minutes resting pedaling, 3-minutes unloaded pedaling and exercise with loaded pedaling). Peak time was defined as the last measurement taken in the exercise period. The primary analysis consisted of a linear mixed effects model with baseline IC measurement as covariate.
次要结局
- Static Inspiratory Capacity (IC) at Day 14(Day 14)
- Trough Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry on Day 14(Day 14)
- Chronic Activity Related Breathlessness Measured by Transition Dyspnoea Index (TDI) at Day 14(Day 14)
- Dyspnoea Measured by Borg CR10 Scale at Day 1, Day 14(Day 1, Day 14)